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510(k) Data Aggregation

    K Number
    K053407
    Device Name
    OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
    Date Cleared
    2006-04-05

    (119 days)

    Product Code
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANALYTICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Analytical Industries Inc. AII 2000 Series Oxygen Analyzers & Monitors are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.
    Device Description
    The AII 2000 Series Oxygen Analyzers and Monitor can be positioned on a table top or pole (tripod wire stand and V-mount dovetail attachments are mounted on the back of the unit) and are readily portable from one location to another. They provide continuous, fast, reliable and accurate oxygen measurements of up to 100% oxygen levels delivered by medical oxygen delivery equipment and respiratory care systems. The heart of each unit is the oxygen sensor, a self-contained galvanic fuel cell sensor. The sensor is specific to oxygen and The relationship between the sensor's signal and changes with the oxygen concentration is both proportional and linear. A battery powered state-of-the-art micro-processor converts the sensor's signal output representing the partial pressure of oxygen in the gas stream being analyzed. The resulting oxygen reading is displayed by a large easy to read backlit liquid crystal display (LCD) that has a resolution of 0.1% oxygen. The microprocessor is controlled from a keypad and provides features like system diagnostics, warning indicators, controls and an alarm capability for continuous monitoring that enhance both safety and effectiveness.
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    K Number
    K002382
    Device Name
    'ALL 2000' % OXYGEN ANALYZER
    Date Cleared
    2001-03-14

    (222 days)

    Product Code
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANALYTICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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